Drug alert: 51 out of 1306 samples declared as NSQ in July 2023

Last Updated on October 2, 2024 by The Health Master

Drug alert: Download the list of NSQ samples for July 2023, the link is given below: The Central Drugs Standard Control Organisation (CDSCO) has declared 51 drug samples out of a total of 1306 drug samples tested as not of standard quality (NSQ), none as misbranded, and 3 as spurious during the month of July 2023.

NSQ List is given below the article

Out of the 1306 samples tested during the month, 1252 came out with standard quality, 51 were declared not of standard quality (NSQ), none were declared misbranded, and 3 were declared spurious.

None of the samples were identified as adulterated; however, 3 declared spurious during the month. Every month, the drug regulator comes up with a list of drugs, medical devices, and cosmetics that are declared not of standard quality, spurious, adulterated, or misbranded.

During the month of June 2023, the authorities tested 1273 samples, out of which 1225 were of standard quality. The number of samples declared as not of standard quality was 48, with none being misbranded and one being spurious.

During the month of May 2023, the authorities tested 1302 samples, out of which 1274 were of standard quality. The number of samples declared as not of standard quality was 27, with none being misbranded and one being spurious.

During the month of April 2023, the authorities tested 895 samples, out of which 859 were of standard quality. The number of samples declared as not of standard quality was 35, with none being misbranded and one being spurious.

During the month of March 2023, the authorities tested 1497 samples, out of which 1149 were of standard quality. The number of samples declared as not of standard quality was 48, with none being misbranded or spurious.

During the month of February 2023, the authorities tested 1251 samples, out of which 1192 were of standard quality. The number of samples declared as not of standard quality was 59, with none being misbranded or spurious.

During the month of January 2023, the authorities tested 1348 samples, out of which 1281 were of standard quality. The number of samples declared as not of standard quality was 67, with none being misbranded or spurious.

During the month of December 2022, the authorities tested 1375 samples, out of which 1305 were of standard quality. The number of samples declared as not of standard quality was 70, with none being misbranded or spurious.

During the month of November 2022, the authorities tested 1487 samples, out of which 1404 were of standard quality. The number of samples declared as not of standard quality was 83, with none being misbranded or spurious.

During the month of October 2022, the authorities tested 1280 samples, out of which 1230 were of standard quality. The number of samples declared as not of standard quality was 50, with none being misbranded or spurious.

During the month of September, 2022, the authorities tested 1456 samples, out of which 1397 were of standard quality. The number of samples declared as not of standard quality was 59, with none being misbranded or spurious.

The test samples were drawn by the zonal and sub-zonal offices of CDSCO, and tested in the drug testing laboratories, i.e CDLs, CDTLs, and RDTLs, in Kolkata, Mumbai, Hyderabad, Chandigarh, and Guwahati.

 

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List of Drugs Declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of July – 2023.

S.No	Name of Drugs/medical device/cosmetics	Batch No.	Date of Manufacture	Date of Expiry	Manufactured By	Reason for failure	Drawn By	From
1	Folic Acid Tablets IP 5mg	T112005	05/2022	04/2024	ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan 173205 H.P.	Description                    & Hydrolysis Products	CDSCO               East Zone Kolkata	CDL Kolkata
2	Tamsulosin Hydrochloride & Dutasteride Tablets (Urimax D)	GH20067	01/2022	12/2024	Cipla Ltd., Verna Indl. Estate, Goa 403722, India	Identification and Assay of Dutasteride and Assay of Tamsulosin Hydrochloride	CDSCO East Zone Kolkata	CDL Kolkata
3	Paracin Plus Suspension (Ibuprofen and Paracetamol Suspension)	KCC24A0 02A1A	04/2023	03/2025	Stadmed Private Limited, 15, Jawpore Road, Kolkata- 700074	Assay of Ibuprofen and Paracetmol	CDSCO East Zone Kolkata	CDL Kolkata
4	Paracin Plus Suspension (Ibuprofen and Paracetamol Suspension)	KCC24A0 01A1A	04/2023	03/2025	Stadmed Private Limited, 15, Jawpore Road, Kolkata- 700074	Assay of Ibuprofen and Paracetmol	CDSCO East Zone Kolkata	CDL Kolkata
5	Ornidazole & Ofloxacin Tablets IP	HOOZ01	07/2022	06/2024	Hindustan Antibiotics Ltd., (A Govt. of India Enterprise) At: 11, W.E.A., Faridabad – 121 001 (Haryana).	Description	CDSCO East Zone Kolkata	CDL Kolkata
6	MONZET (Montelukast Sodium and Levocetrizine Hydrochloride Tablets IP)	DMZT- 2205	12/2022	11/2024	Kniss Laboratories Pvt. Ltd., No.9, Multe Industrial Estate, Gerugambakkam, Chennai- 600128.	Dissolution	CDSCO East Zone Kolkata	CDL Kolkata
7	Lonapam® MD 0.5 (Clonazepam Mouth Dissolving Tablets 0.5 mg)	43L22T01	03/2022	02/2025	Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan-391240, Dist.: Vadodara (Gujarat)	Related Substances	CDSCO East Zone Kolkata	CDL Kolkata

8	Lonapam® MD 0.5 (Clonazepam Mouth Dissolving Tablets 0.5 mg)	43L23T01	02/2023	01/2026	Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan-391240, Dist.: Vadodara (Gujarat)	Related Substances	CDSCO East Zone Kolkata	CDL Kolkata
9	Lonapam® MD 0.5 (Clonazepam Mouth Dissolving Tablets 0.5 mg)	43L22T03	09/2022	08/2025	Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan-391240, Dist.: Vadodara (Gujarat)	Related Substances	CDSCO East Zone Kolkata	CDL Kolkata
10	Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml)	M481005	07/2021	06/2023	Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C. Satpur, Nashik, Maharashtra 422 007	Assay of Flucloxacillin	CDSCO West Zone Mumbai	CDL Kolkata
11	Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml)	M481006	07/2021	06/2023	Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C. Satpur, Nashik, Maharashtra 422 007	Assay of Flucloxacillin	CDSCO West Zone Mumbai	CDL Kolkata
12	Neomycin Sulphate Ointment USP 20 gm	023	03/2023	02/2025	Deep Pharma, Unit-2, Survey No. 293/3, Behind Jalaram Mandir, Kalikund Kheda Road, Dholka, Ahmedabad- 382225, Gujarat	Assay of Neomycin	CDSCO Ahmedabad	CDL Kolkata
13	PYRITOL (Paracetamol Injection) 2ml	HIPM220 08B	12/2022	11/2024	Health Biotech Ltd., Village: Sandoli, Nalagarh Road, Baddi, Dist. Solan (HP) India 173205	Particulate Matter	CDSCO Ahmedabad	CDL Kolkata
14	Rabeprazole Gastro-Resistant Tablets IP 20 mg	AT23029	02/2023	01/2025	Alves Healthcare Private Limited, Village Nangal Uperla, Swarghat Road, Tehsil, Nalagarh, Dist. Solan – 174101 (H.P.), India	Dissolution	CDSCO Ahmedabad	CDL Kolkata
15	SN-15 Plus (Serratiopeptidase & Diclofenac Potassium Tablets)	DS-407	10/2022	09/2024	Ruby Organics Pvt. Ltd., D- 79, T.T.C, M.I.D.C, Turbhe, Navi Mumbai-400705.	Disintegration	CDSCO Hyderabad	CDL Kolkata

16	Ondansetron Injection IP	L3003	11/2022	10/2024	Captab Biotic, Unit-II, Plot No.125, EPIP Road, Mauja Jharmajri, Baddi, Distt. Solan H.P. 173205.	Description and Particulate Matter	Drug Control Department Himachal Pradesh	CDL Kolkata
17	Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) RL 500 ml	ODF 221292	12/2022	11/2024	Haseeb Pharmaceuticals Pvt. Ltd., Plot No. F 9/14, 15, 16, MIDC, Nagpur-440016.	Particulate Contamination	Drug Control Department Odisha	CDL Kolkata
18	Diclofenac Sodium, Paracetamol and Serratiopeptidase Tablets	F23018	02/2023	01/2026	Brussels Laboratories Pvt. Ltd., 33, Changodar Ind. Estate, Sarkhej Bavla Road, Changodar – 382210, Ahmedabad, Gujarat.	Assay of Serratiopeptidase	CDSCO Ahmedabad	CDL Kolkata
19	Carbamazepine Tablets IP 200 mg	GCB5	12/2022	11/2024	Super Formulations Pvt. Ltd., 16-B & 15-F, Industrial Area, Maxi Road, Ujjain (M.P.)-456010.	DISSOLUTION	CDSCO Zonal Office Chennai	CDTL Chennai
20	Norfloxacin Tablets IP 400 mg	NRT2300 9	01/2023	12/2024	Vivek Pharmachem (India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303 102.	DISSOLUTION	CDSCO Subzonal Office Bangalore	CDTL Chennai
21	Chymovit Forte (Trypsin- Chymotrypsin Tablets)	DMT0027 J	01/2023	12/2024	DM PHARMA PRIVATE LIMITED., Vill. Bhud, NH- 21A, Baddi, Distt. Solan (H.P.) 173 205	Uniformity of Weight, Average Weight & Disintegration test (Acid stage)	CDSCO West-Zone Mumbai	CDTL Mumbai
22	Trypsin-Chymotrypsin Tablets (Chymnetra-Forte)	DT1624H	12/2022	11/2024	DM PHARMA PRIVATE LIMITED., Vill. Bhud, NH- 21A, Baddi, Distt. Solan (H.P.) 173 205	Uniformity of Weight, & Average Weight	CDSCO West-Zone Mumbai	CDTL Mumbai
23	Amoxycillin & Potassium Clavulanate Tablets I.P. 625 mg	422-494A	03/2022	02/2024	Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib- 173 025	Assay	CDSCO West-Zone Mumbai	CDTL Mumbai

24	Tropicamide Eye Drops IP 1 % w/v	GTC002	05/2022	04/2024	Vivimed Labs Limited., Plot No.8, Phase V, IDA, Jeedimetla, Medchal- Malkajgiri, Dist. Telangana State – 500 055	Sterility & Assay	CDSCO West-Zone Mumbai	CDTL Mumbai
25	Cyproheptadine Hydrochloride Syrup IP (Hungree Syrup)	30489	03/2023	02/2025	Zenith Drugs Pvt. Ltd., 72/5, Muradpura (Orangpura) Dhar Road, Near Kalaria, Indore 453001 (MP) India	pH	CDSCO Indore	CDTL Mumbai
26	AMLODIPINE AND ATENOLOL TABLETS IP (ALAMO -AT)	MDG281 K	11/2022	10/2024	M.R. HEALTHCARE PVT. LTD. Village : Tanda Mallu, Kashipur Road, Ramnagar – 244715, Dist. Nainital, Uttarakhand( INDIA)	Assay of Amlodipine Besilate equivalent to Amlodipine Only	CDSCO                   Zonal Office Hyderabad	CDTL, HYDERABAD
27	ONDANSETRON ORALLY DISINTEGRATING TABLETS IP (ONDAPLUS-MD 4)	GT23030 56B	03/2023	02/2025	Roseate Medicare., Vill. Anji, Bypass Road, P.O. Barog, Tehsil & Distt. Solan, 173211 (H.P.) INDIA.	Test for Disintegration	CDSCO             Zonal Office            Hyderabad	CDTL, HYDERABAD
28	AMOXYCILLIN AND POTASSIUM CLAVULANATE ORAL SUSPENSION I.P. (TRUECLAM DS)	PM-16064	09/2022	02/2024	PERENNIAL MEDICARE, Shamti, Solan-173212 (H.P.)	pH and Assay	CDSCO             Zonal Office            Hyderabad	CDTL, HYDERABAD
29	ALBENDAZOLE TABLETS I.P. 400 mg (FOZY)	RD09- 2202	10/2022	09/2024	Vance & Health Pharmaceuticals Pvt. Ltd., Khasra No. 410, Karondi, Roorkee-247 667, Uttarakhand	Test for Dissolution	CDSCO Port Office Visakhapatnam	CDTL, HYDERABAD
30	Olmesartan Medoxomil Tablets IP 40 mg	GT22183 1	10/2022	09/2024	Theon Pharmaceuticals Ltd., Vill.Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.) 174101	Dissolution	CDSCO North Zone	RDTL Chandigarh
31	Aluminium Hydroxide (0.291 gm), Magnesium Hydroxide (98 mg) and Oxetacaine (10 mg )Gel	ML22076 1	11/2022	10/2024	Mascot Health Series Pvt. Ltd, Plot No. 79,80, Sec-6A, IIE, Sidcul, Haridwar 249403	Assay of Oxetacaine	CDSCO North Zone	RDTL Chandigarh

32	Sodium Valproate and Valproic Acid Controlled Release Tablets 500 mg	422-2202	12/2022	11/2024	ZEE LABORATORIES LTD., Behind 47, Industrial Area, Paonta Sahib-173025	Identification of Valproic Acid and Assay of Valproic Acid and Sodium Valproate	CDSCO North Zone	RDTL Chandigarh
33	Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30 mg)	RPE-2258	07/2022	06/2024	Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee-247667 (U.K.)	Assay of Rabeprazole Sodium	CDSCO North Zone	RDTL Chandigarh
34	Itraconazole Capsules 100 mg	Z22-293	03/2022	02/2024	Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025	Dissolution	CDSCO North Zone	RDTL Chandigarh
35	Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (Glimipulse M1 Tablets)	SGT- 0624A	12/2022	11/2024	Saitech Medicare Pvt. Ltd., Village-Kheri, Trilokpur Road, Kala-Amb, Distt. Sirmour, (H.P.) 173030	Assay of Glimepiride	CDSCO                     Sub- Zone     Baddi	RDTL Chandigarh
36	Rosuvastatin Tablets IP (Rosuvas 10 Tablets)	SID3056A	11/2022	04/2025	Sun pharma laboratories ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East- Skkim-737135	Description and Assay of Rosuvastatin Calcium calculated as Rosuvastatin	Drug Control Department Delhi	RDTL Chandigarh
37	Nimesulide and Paracetamol Tablets (CDNIM-P TABLETS)	SMP- 2205	01/2023	12/2024	Cyper Pharma, K.No. 825- 827, Vill.Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) 173205 INDIA	Uniformity of weight and Assay of Nimesulide and Paracetamol	Drug Control Department Himachal Pradesh	RDTL Chandigarh
38	Calcium Carbonate with Vitamin D3 Tablets (CYPCAL-FORTE TABLETS)	CLF- 22013	11/2022	10/2024	CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 INDIA	Assay of Vitamin D3	Drug Control Department Himachal Pradesh	RDTL Chandigarh
39	Albendazole Tablets IP 400 mg	ABD-2206	01/2023	12/2024	CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205	Dissolution	Drug Control Department Himachal Pradesh	RDTL Chandigarh
40	Indomethacin Capsules IP (INDOMETHACIN CAPSULES)	IND-2202	02/2023	01/2026	CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 INDIA	Uniformity of weight and Assay of Indomethacin	Drug Control Department Himachal Pradesh	RDTL Chandigarh

41	Griseofulvin Tablets IP 250 mg (Grisowin-250 Tablets)	GSP- 22B08	01/2023	12/2024	CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 (India)	Uniformity of weight and Assay of Griseofulvin	Drug Control Department Himachal Pradesh	RDTL Chandigarh
42	Ampicillin Capsules IP (ampicillin Capsules IP-250)	AMP- 22A07	01/2023	12/2024	Cyper Pharma, K.No. 825- 827, Vill. Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) 173205 INDIA	Assay of Ampcillin Trihydrate calculated as Ampicillin	Drug Control Department Himachal Pradesh	RDTL Chandigarh
43	Furosemide Tablets IP 40mg (Furosemide-40)	T212721	03/2022	02/2024	United Bioceuticals Pvt. Ltd. Plot No. 33C, Industrial Part- IV, Begumpur, Haridwar- 249402 Uttarakhand	Dissolution	Drug Control Department Nagaland	RDTL, Guwahati
44	MULTIELECTROLYTE WITH 20% w/v DEXTROSE INJECTION (INTALYTE (Veterinary)	IN703401 1	03/2023	02/2026	Abaris Healthcare Pvt. Ltd., Survey No. 1407-11, Village Rajpur, Tal. Kadi. Dist. Mehsana-382740 (Gujarat)	Particulate Contamination, Sterility and Description	Drug Control Department Bihar	RDTL, Guwahati
45	Telmisartan Tablets I.P. 40mg.	T101004	09/2021	08/2023	ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205 (H.P.), India	Description	Drug Control Department Bihar	RDTL, Guwahati
46	Paraccetamol Tablets I.P. 500 mg	DGT22- 257	06/2022	05/2024	ORNATE LABS PVT. LTD. Bela Industrial Estate, Muzaffarpur- 842005	Dissolution and Assay	Drug Control Department Bihar	RDTL, Guwahati
47	DEXADEC INJECTION (Dexamethasone Sodium Phosphate Injection I.P. 2 ml.)	TGL0223 0317	02/2023	01/2025	T & G Medicare, Vill. Kunjhal, P.O. Baddi, Dist. Solan, H.P.	Sterility and BET	Drug Control Department Arunachal Pradesh	RDTL, Guwahati
48	OFLOXACIN & ORNIDAZOLE TABLETS I.P. (OFNI-OZ)	AT220708 27	07/2022	06/2024	Accura Care Pharmaceuticals pvt. Ltd., Vill. Moginand, Nahan Road, Kala Amb. Distt- Sirmour (H.P.) 173030	Dissolution of Ofloxacin and Ornidazole	CDSCO Sub Zone, Guwahati	RDTL, Guwahati

S.No	Name of Drugs/medical device/cosmetics	Batch No.	Date of Manufacture	Date of Expiry	Manufactured By	Reason for failure	Drawn By	From	Remarks
49	Pantoprazole Gastro- Resistant and Domperidone Prolonged Release Capsules IP (PAN-D)	23440762	03/2023	02/2025	Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit- 2, Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137	Identification & Assay of Pantoprazole & Domperidone (Sample is deemed to be Spurious)	CDSCO East Zone Kolkata	CDL Kolkata	The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation.
50	Amoxycillin and Potassium Clavulanate Tablets IP (CLAVAM 625)	23440774	03/2023	08/2024	Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit- 2, Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137	Identification & Assay of Amoxycillin and Clavulanic Acid (Sample is deemed to be Spurious)	CDSCO East Zone Kolkata	CDL Kolkata	The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation.
51	Pantoprazole Gastro- resistant Tablets IP (PAN 40)	23440087	01/2023	06/2025	Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit- 2, Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137	Dissolution	CDSCO East Zone Kolkata	CDL Kolkata	The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation.

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